Status:
WITHDRAWN
Feasibility of Transvaginal Cholecystectomy
Lead Sponsor:
Mayo Clinic
Conditions:
Gallstones
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Today there are three different ways to remove a gallbladder with gallstones. Surgeons can remove the gallbladder through small incisions in the abdomen. This is called laparoscopic cholecystectomy. I...
Detailed Description
As technologic innovations in medicine continue to advance, less intrusive operative procedures are being developed. Natural Orifice Transluminal Endoscopic Surgery (NOTES) may represent a less invasi...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Female patients undergoing elective cholecystectomy for cholelithiasis.
- Exclusion criteria
- Male patients, patients \<18 years or \>65 years of age
- Pregnant patients
- Patients with prior pelvic surgery
- Patients with prior hepatobiliary surgery or other major abdominal surgery
- Patients with ASA class \>3
- Patients with BMI \>35
- Patients with risk factors for requiring an open cholecystectomy (e.g. possible gallbladder cancer, acute cholecystitis, jaundice)
- Patients who cannot provide consent for the study
- Patients not willing to participate in the study.
- Patients with common bile duct stones
- Patients with evidence of abdominal abscess or mass
- Patients with diffuse peritonitis
- Patients with a clinical diagnosis of sepsis
- Patients with coagulopathy or using anticoagulants or anti-platelet agents (aspirin up to 81mg/day acceptable)
- Patients with planned concurrent procedures
- Patients with a prior diagnosis of intra-abdominal adhesions
- Patients who are participating in any other investigational device or drug trial that has not yet completed the primary endpoint
- Patients with an enlarged uterus
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01232959
Start Date
October 1 2010
End Date
December 1 2012
Last Update
January 13 2016
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